MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	B2-70071-D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd administration set was damaged.The following information was provided by the initial reporter, translated from finnish to english: two separate incidents on (b)(6) and (b)(6) in one, the valve plug broke and started to leak during the infusion, in the other, the valve plug broke during flushing.In both cases, the valve plug filled with blood as it was being pumped and blood started to leak through the plug.The situation was corrected when the plug was replaced.There is a valve plug with positive displacement in the peripheral and central veins.
Additional Manufacturer Narrative
No b2-70071-d product was available for investigation.The customer reported that the affected samples were from lot 25065283 and stated that "the valve plug broke and started leaking during the infusion" and that "the valve plug broken during flushing." the customer further noted that in both cases, "the valve plug was pushed into the vein and bleeding had already started from the plug." additional follow-up from the customer indicated that the issue occurred approximately one hour after the start of the infusion.They described the plug as appearing as though "the entire valve plug had exploded and was filled to the brim with blood," with no noticeable change in its external appearance prior to the event.They also confirmed that a needle was not used and that "the valve cap was replaced every day after the infusion." the details of this feedback were forwarded to the manufacturing site for investigation.The root cause of the customer's experience could not be determined as the sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer's experience.A review of the production records for lot 25065283 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The quality team at the manufacturing site has been informed of this complaint in order to be aware of the reported failure mode during future production of this product.A review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the b2-70071-d product over the past 12 months.
Event or Problem Description
No additional information.

• Brand Name: BD ADMINISTRATION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24288683
• Report Number: 9616066-2026-00253
• Device Sequence Number: 9332832
• Product Code: FPA
• UDI-Device Identifier: 00814371020150
• UDI-Public: (01)00814371020150
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: B2-70071-D
• Device Lot Number: 25065283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/08/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown